PARCUS MEDICAL LLC

Parcus Medical LLC specializes in orthopedic and arthroscopic devices, primarily focused on tendon and ligament repair. Their product line includes non-bioabsorbable and bioabsorbable tendon/ligament bone anchors (like the V-LoX and Twist PEEK Suture Anchor), reusable surgical tools such as cannulated and fluted drill bits and bone taps, as well as multifilament sutures made from polyolefin/fluoropolymer and polyester. They also produce surgical instrument racks and arthroscopic accessories, such as the Actiflip and various guide instruments.

Parcus Medical LLC is based in the United States, which means their devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II, depending on risk level and intended use. Since the company is U.S.-based, their devices are subject to FDA’s regulatory pathways, including pre-market submissions (like 510(k)s for Class II) and compliance with U.S. manufacturing and labeling requirements.

Parcus Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling transparent tracking, reporting, and compliance monitoring. This registry helps healthcare providers, regulators, and other stakeholders verify device details, such as manufacturer information, specifications, and regulatory classification.

The FDA classifies Parcus Medical LLC’s devices as either Class I or Class II. Class I devices generally pose minimal risk and may only require general controls (e.g., proper labeling and manufacturing practices), while Class II devices involve moderate risk and require additional premarket submissions (like a 510(k)) to demonstrate safety and effectiveness. For example, bone anchors and sutures are often Class II due to their role in critical orthopedic procedures, whereas reusable drill bits may fall under Class I if they have a lower risk profile.

Parcus Medical LLC offers reusable surgical tools like cannulated and fluted drill bits and bone taps, which are designed for repeated use with proper sterilization between procedures. These tools are engineered for durability and precision, reducing waste compared to single-use alternatives. Reusable devices must meet stringent FDA requirements for sterilization validation, cleaning protocols, and material compatibility to ensure patient safety and device integrity over multiple uses, unlike disposable items that are used once and discarded.